Cardiovascular Health Promotion Among African-Americans by FAITH!

Obesity Clinical Trial

— FAITH!  

Official title:

Cardiovascular Health Promotion Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health): Engaging the Community Through Mobile Technology-assisted Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084822
• Other study ID #: 16-000353
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: June 2018

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of healthy lifestyles for CVD prevention and provide support for behavior change.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Basic Internet navigation skills, at least weekly Internet access, active email address, minimal fruit/vegetable intake (<5 servings/day), no regular physical activity program (< 30 minutes/d of moderate physical activity), able to engage in moderate physical activity (no restrictions)

Exclusion Criteria:

• Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Diabetes Mellitus
• Diet Modification
• High Cholesterol
• Hypercholesterolemia
• Hypertension
• Obesity
• Physical Activity
• Pre Diabetes
• Prediabetic State
• Prevention
• Smoking Cessation

Intervention

Behavioral:
• FAITH! App digital intervention
The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Mayo Clinic Center for Clinical and Translational Science (CCaTS), Mayo Clinic Clinic Center for Innovation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet (fruit/vegetable intake using adaptation of NIH Eating at America's Table Quick Food Scan Screener)	Change in self reported diet	28 weeks post-intervention
Primary	Physical activity behavior	Change in self-reported physical activity, reported as minutes per week of moderate to vigorous physical activity	28 weeks post-intervention
Primary	Diet self-efficacy (using Self-Efficacy and Eating Habits Survey)	Change from baseline self-efficacy; scale of 1-5; Healthy diet score components include the following: fruits and vegetables, =4.5 cups/d; fish, 2 or more 3.5-oz servings/wk; fiber-rich whole grains (=1.1 g fiber/10 g carbohydrate), 3 or more 1-oz-equivalent servings/d; sodium, =1500 mg/d; and sugar-sweetened beverages, =450 kcal/wk. Dietary recommendations are scaled according to a 2000-kcal/d diet.	28 weeks post-intervention
Primary	Physical activity self-efficacy (using Self-Efficacy and Exercise Habits Survey)	Change from baseline self-efficacy. Physical activity is reported via the Self-Regulation Scale from Health Beliefs Survey, which includes 10 items, using a 5-point Likert scale (1=never to 5=always) with higher scores indicating higher PA self-regulation	28 weeks post-intervention
Secondary	Intervention feasibility	Participant retention (goal >80% of enrolled participants)	28 weeks post-intervention
Secondary	BMI	Change from baseline BMI	28 weeks post-intervention
Secondary	Blood Pressure	Change from baseline blood pressure	28 weeks post-intervention
Secondary	Fasting Cholesterol	Change from baseline cholesterol	28 weeks post-intervention
Secondary	Fasting glucose	Change from baseline fasting glucose	28 weeks post-intervention
Secondary	Smoking (using adaptation of Global Adult Tobacco Survey)	Change in self reported smoking status	28 weeks post-intervention
Secondary	Life's Simple 7 Composite Score	Change from baseline Life's Simple 7 Composite Score; calculated as a composite of each LS7 component by assigning 2 points for ideal, 1 point for intermediate, or 0 points for poor. The total composite score is assessed on a scale of 0 to 14 points. To categorize, scores of 0 to 6 were labeled "poor', 7 to 8 "intermediate" and 9 to 14 "ideal" cardiovascular health.	28 weeks post-intervention
Secondary	Cardiovascular health knowledge	Change in percent correct from baseline knowledge and attitudes about CVD	28 weeks post-intervention